New EU project works on improving guidelines for Informed Consent, including vulnerable populations

The informed consent (IC) process allows an individual; to voluntarily decide whether or not to participate in research.

Autonomy of the patient in the decision of having a medical procedure or participating in clinical research is of major importance. Here’s why:

Generally, ICs are difficult to read documents that do not include all stakeholders’ perceptions. Therefore, informative IC should be a process that includes needed information under a gender and age perspective, more importantly if these are vulnerable populations.

Therefore, the main objective of I-Consent is to develop guidelines on how to present IC to citizens, so that they are comprehensive and facilitate participation of citizens in research.

In particular, MRF will work with patient groups from across Europe to gather feedback and perspectives on existing issues and challenges relating to informed consent for vaccine trials in adults, adolescents and pregnant women against serious diseases including meningitis. Ultimately we hope to reach consensus on how issues should be prioritized in terms of their importance and difficulty, in addition to further exploring potential solutions to identified challenges.

Specific objectives of I-Consent:

• Identify gaps, barriers and challenges, and prioritize needs, requirements and areas for action in the process of IC
• Develop tailored strategies to inform the development of informed consent
• Create and validate guidelines to develop comprehensive IC that improve citizens’ participation in research.

The I-Consent project, worth approximately 3 million euros, was granted within the Horizon 2020 Program of the European Union after a competitive one stage selection process. The project started with a kick-off meeting in Valencia (Spain) on the 11th & 12th of May 2017 and will be funded for three years.